NCT04349072

A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM \[also known as HOCM\]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.

Conditions

• HOCM, Hypertrophic Obstructive Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Mavacamten	Mavacamten Capsules Other names: MYK-461
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-07-06
• Primary completion: 2022-02-07
• Completion: 2024-05-20
• First posted: 2020-04-16
• Last updated: 2025-05-23
• Results posted: 2023-03-07

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study